Drug Compounding Safety Legislation Approved by House, Will Move to Senate

The U.S. House of Representatives approved the Drug Quality and Security Act, legislation to improve security in the drug supply chain and the safety of compounded drugs, this past weekend by voice vote.

If passed, the law would allow sterile drug compounding facilities to register as "outsourcing facilities," which would be subject to oversight by the Food and Drug Administration.

Such facilities would have to comply with certain manufacturing practices, event reporting, risk-based inspections and labeling requirements.

The bill proposes a system for stronger communication between the FDA and states during problems related to compounded drug products. A "track and trace" provision would implement a serial number system to track prescription drugs from the manufacturer to the dispenser

The bill also mandates stronger licensure requirements for third-party logistics providers and wholesale distributors. 

The bill will now travel to the Senate. 

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